USPTO Patents Application 10687850

United States Patent and Trademark Office

UNITED STATES DEPARTMENT OF COMMERCE
I nihil Stall-, l'atint and Trademark Office

Address: COMMISSIONER FOR PATENTS

APPLICATION NO.

FILING DATE

FIRST NAMED INVENTOR

ATTORNEY DOCKET NO. CONFIRMATION NO.

10/687,850 10/17/20(

7590

Troy J. Cole

Bank One Center/Tower

Suite 3700

111 Monument Circle
Indianapolis, IN 46204-5137

David W.Burke

NOGUEROLA, ALEXANDER STEPHAN

PAPER NUMBER

DELIVERY MODE

Please find below and/or attached an Office communication concerning this application or proceeding.

The time period for reply, if any, is set in the attached communication.

PTOL-90A (Rev. 04/07)

l/ffflrC? nVrliUli Otfff Iff ids y

Application No.

10/687,850

Applicant(s)
BURKE ET AL.

Examiner

ALEX NOGUEROLA

Art Unit

1795

- The MAILING DATE of this communication appears on the cover sheet with the correspondence address —
Period for Reply

A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTH(S) OR THIRTY (30) DAYS,
WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.

- Extensions of time may be available under the provisions of 37 CFR 1 .136(a). In no event, however, may a reply be timely filed
after SIX (6) MONTHS from the mailing date of this communication.

- If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.

- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
earned patent term adjustment. See 37 CFR 1 .704(b).

Status

1 )|EI Responsive to communication(s) filed on 12/29/2008 (RCE) .
2a )□ This action is FINAL. 2b)^ This action is non-final.

3) D Since this application is in condition for allowance except for formal matters, prosecution as to the merits is

closed in accordance with the practice under Ex parte Quayle, 1935 CD. 11, 453 O.G. 213.

Disposition of Claims

4) ^ Claim(s) 1-16 is/are pending in the application.

4a) Of the above claim(s) is/are withdrawn from consideration.

5) ^ Claim(s) 7-15 is/are allowed.

6) |EI Claim(s) 1-6 and 16 is/are rejected.

7) 0 Claim(s) is/are objected to.

8) D Claim(s) are subject to restriction and/or election requirement.

Application Papers

9) Q The specification is objected to by the Examiner.

10) D The drawing(s) filed on is/are: a)D accepted or b)D objected to by the Examiner.

Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).

1 1) D The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.

Priority under 35 U.S.C. § 119

12) D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
a)D All b)D Some * c)D None of:

1 .□ Certified copies of the priority documents have been received.

20 Certified copies of the priority documents have been received in Application No. .

3.Q Copies of the certified copies of the priority documents have been received in this National Stage
application from the International Bureau (PCT Rule 17.2(a)).
* See the attached detailed Office action for a list of the certified copies not received.

Attach ment(s)

1) D Notice of References Cited (PTO-892) 4) □ Interview Summary (PTO-41 3)

2) □ Notice of Draftsperson's Patent Drawing Review (PTO-948) Paper No(s)/Mail Date. .

3) □ Information Disclosure Statement(s) (PTO/SB/08) 5 ) □ Notice of Informal Patent Application

Paper No(s)/Mail Date . 6) □ Other: .

PTOL-T26 d (Rev e 08-06r

Office Action Summary

Part of Paper No./Mail Date 20090121

Application/Control Number: 10/687,850
Art Unit: 1795

Page 2

DETAILED ACTION

Response to Arguments

1 . Applicant's arguments filed December 29, 2008 ("Amendment") have been fully
considered but they are not persuasive. The Examiner acknowledges that Neel only
applies a DC signal to the second pair of electrodes in his test strip. The Examiner also
acknowledges that Beaty applies an AC signal or an AC signal with DC offset, that is, a
signal having an AC component, to a test strip having only one pair of electrodes. The
Examiner also agrees that one reason, although not the only reason, Neel uses a
separate pair of electrodes to determine sample volume sufficiency to avoid perturbing
the sample before measurement. The Examiner does not agree, though, that Beaty is
incompatible with Neel.

Even, arguendo, Applicant is correct in stating, "There is no teaching in Beaty of
using a DC offset during the sample volume determination" (top of page 1 1 of the
Amendment) there is still motivation to provide a signal having an AC component to the
second pair of electrodes in Neel. Indeed, Applicant provides the motivation, "It is well
known in the art that a DC bias voltage on the sample/reagent is to be avoided until it is
desired to begin the analyte measurement test to determine the Cottrell decay curve."
Applicant then cites several patents in support of this assertion. See the bottom of page
8 of the Amendment, bridging to page 9. So, the second pair of electrodes allows for

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Art Unit: 1795

determining sample volume using an AC component while also allowing determining the
concentration of the interferants with a DC bias, as taught by Beaty, without perturbing
the sample. Applicant alleges that both the AC component and DC bias are used to
determine the concentration of the interferants. See the bottom of page 10 of the
Amendment. However, the Examiner respectfully disagrees. The low magnitude AC
voltage excitation voltage referred to in column 1 1 , lines 32-46 in Beaty clearly can be
used for sample identity, sample volume, sample temperature/hematocrit, ... See the
immediately preceding paragraph, col. 11:17-31. A fair reading of col. 11:16-46 in the
Examiner's view teaches that the DC bias is used to determine the concentration of the
interferants. Even, arguendo, Applicant's interpretation is correct, which the Examiner
does not concede, it is moot because (1 ) there is still the benefit of a having a second
pair of electrodes to avoid perturbing the sample when making measurements other
than for measuring the analyte of interest, and (2) none of claims 1-6 require that the
second test signal is measuring sample volume. The information gleaned form the
second response is not limited at all.

For the reasons set forth above, Applicant's arguments with regard to the
rejections of claims 1-6 are not persuasive.

Application/Control Number: 10/687,850
Art Unit: 1795

Page 4

Claim Rejections - 35 USC § 103

1 . The text of those sections of Title 35, U.S. Code not included in this action can
be found in a prior Office action.

2. Claims 1-5 and 16 are rejected under 35 U.S.C. 103(a) as being unpatentable
over Neel et al. US 6,743,635 B2 ("Neel") in view of Beaty et al. (US 6,645,368 B1)
("Beaty") and Ohara et al. US 6,193,873 B1 ("Ohara").

Addressing claim 1, Neel discloses a method of performing a measurement on a
biological fluid in a test strip (abstract) comprising

providing a biological fluid test strip (10) including

a capillary fill chamber (66) extending a length along the test strip from an intake
opening (68) to a terminus (70)(Figures 1-3),

a first pair of electrodes (22,24) in operative communication with the
chamber (Figure 2),
and

a second pair of electrodes (28,30) in operative communication with the
chamber (Figure 2);

dosing the test strip with a biological fluid effective to cause the biological
fluid to flow from the intake opening toward the terminus (col. 14:43-51);

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Art Unit: 1795

applying a first test signal to at least one of the first pair of electrodes
(col. 14:48-55);

measuring a first response to the first test signal (col. 14:48-55);

maintaining the first pair of electrodes in an inoperative state after the
measuring the first response (col. 14:55-57);

applying a second test signal to at least one of the second pair of
electrodes

(col. 14:67 -col. 15:03);

measuring a second response to the second test signal (col. 14:67 -
col. 15:03); and

performing a measurement upon the biological fluid after the measuring
the second response (col. 15:26-28).

The second test signal applied by Neel appears to be just a DC test signal
(col. 14:67 -col. 15:03).

Beaty discloses applying an AC test signal to test electrodes to determine
sample volume sufficiency and/or other parameters, such as sample temperature, and
sample identity/hematocrit in an electrochemical test strip for determining the
concentration of a medically significant component of a biological fluid. See the
abstract; Figure 2; col. 06:20-42; and col. 11:16-30. The AC test signal may have DC
bias to allow the determination of concentration of interferants of interest.

It would have been obvious to one with ordinary skill in the art at the time of the
invention to use an AC test signal or a signal having both an AC component and a DC

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Art Unit: 1795

component as taught by Beaty in the invention of Neel as the second test signal
because as taught by Beaty with an AC signal both sample identity and sample volume
can then be determined with little affect from hematocrit, glucose (or other analyte)
concentration, temperature, bilirubin concentration, uric acid concentration, and oxygen
concentration; and with an additional DC bias in the second signal the concentrations
of interferants may be determined without perturbing the sample. See 06:20-42 and
col. 1 1 :16-44. Moreover, as shown by Ohara it was known at the time of the invention
that measurements other than for analyte concentration should not perturb the sample:
"For accurate results, the sample detection procedure should not perturb the analyte
concentration, ..." See col. 02:01-4.

Addressing claim 2, Neel et al discloses the measuring of the first response to
the first test signal is indicative of contact between the first pair of electrodes and the
biological fluid (Column 14, lines 48-51).

Addressing claim 3, Neel et al discloses measuring the first response to the first
test signal to indicate contact of the first pair of electrodes and the fluid (Column 14, line
63 through Column 1 5, line 1 1 ).

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Art Unit: 1795

Page 7

Addressing claim 4, Neel et al discloses measuring the second response to the
second test signal to indicate contact of the second pair of electrodes and the fluid
(Column 14, lines 48-55).

Addressing claim 5, Neel et al discloses performing a measurement on the

biological fluid by applying a test signal to at least one of the first pair of electrodes
(Column 15, lines 47-58).

Addressing claim 16, for the additional limitation of this claim note that Beaty
teaches that the second test signal may be a pure AC signal or may have a DC offset.
See col. 06:20-57 and col. 1 1 :32-36.

3. Claim 6 is rejected under 35 U.S.C. 103(a) as being unpatentable over Neel et al.
US 6,743,635 B2 ("Neel") in view of Beaty et al. US 6,645,368 B1 ("Beaty") as applied

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Art Unit: 1795

to claims 1-5 and 16 above, and further in view of Feldman et al. US 6,592,745 B1
("Feldman").

Neel does not mention providing a third pair of electrodes in operative
communication with the chamber wherein the performing a measurement upon the
biological fluid includes applying a measurement test signal to at least one of the third
pair of electrodes.

Feldman discloses an electrochemical biosensor for performing a measurement
on a biological fluid. The biosensor comprises multiple working electrodes (42, 44, 46),
along with counter electrodes, to form electrode pairs that are in operative
communication with a sample chamber (26) on a base material (48) (col. 49:7-12). It
would have been obvious to provide at least one additional pair of electrodes, to form a
third electrode pair, as taught by Feldman in the invention of Neel as modified by Beaty
because as taught by Feldman, "... multiple electrode sensors may be used to test a
variety of analytes using a single sample ..." and "[m]ultiple electrode sensors may also
be used to improve the precision of the resulting readings See col. 48:16-59.

Allowable Subject Matter

4.

Claims 7-15 are allowed.

Application/Control Number: 10/687,850
Art Unit: 1795

Page 9

5 . Any inquiry concerning this communication or earlier communications from the
examiner should be directed to ALEX NOGUEROLA whose telephone number is (571) 272-
1343. The examiner can normally be reached on M-F 8:30 - 5:00.

If attempts to reach the examiner by telephone are unsuccessful, the examiner's
supervisor, NAM NGUYEN can be reached on (571) 272-1342. The fax phone number for the
organization where this application or proceeding is assigned is 571-273-8300.

Information regarding the status of an application may be obtained from the Patent
Application Information Retrieval (PAIR) system. Status information for published applications
may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
applications is available through Private PAIR only. For more information about the PAIR
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system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).

/Alex Noguerola/

Primary Examiner, Art Unit 1795

February 2, 2009